TriangleNCT02643303 · OUTCOME
Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- up to 15 months
What was measured
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measured Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria.
Analysis population: All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment.
Groups in this outcome
Phase 1, Cohort 1A
Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC
Phase 1, Cohort 1B
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Cohort 1C + Phase 2; Sarcoma
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Cohort 1C + Phase 2; Merkel Cell Carcinoma
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
Cohort 1C + Phase 2; Solid Tumors With Accessible Masses
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
| Group | Source count |
|---|---|
| Phase 1, Cohort 1A | 4 |
| Phase 1, Cohort 1B | 4 |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 1 |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 14 |
| Cohort 1C + Phase 2; Sarcoma | 7 |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 4 |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 9 |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 2 |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 6 |
Reported measurements
Source class 1
irCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1A | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 1B | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Sarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 0 | Not reported | Not reported | Not reported | Not reported |
irPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1A | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 1B | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Sarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 0 | Not reported | Not reported | Not reported | Not reported |
irSD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1A | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 1B | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Sarcoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 3 | Not reported | Not reported | Not reported | Not reported |
irPD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1A | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 1B | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Sarcoma | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- irCR
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- irPR
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 3
- title
- irSD
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 3
- title
- irPD
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 6
- units
- Participants
- description
- Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measured Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria.
- groups
- description
- Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC
- id
- OG000
- title
- Phase 1, Cohort 1A
- description
- Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
- id
- OG001
- title
- Phase 1, Cohort 1B
- description
- Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
- id
- OG002
- title
- Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
- description
- Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
- id
- OG003
- title
- Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer
- description
- Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
- id
- OG004
- title
- Cohort 1C + Phase 2; Sarcoma
- description
- Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
- id
- OG005
- title
- Cohort 1C + Phase 2; Merkel Cell Carcinoma
- description
- Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
- id
- OG006
- title
- Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies
- description
- Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
- id
- OG007
- title
- Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases
- description
- Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
- id
- OG008
- title
- Cohort 1C + Phase 2; Solid Tumors With Accessible Masses
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- up to 15 months
- title
- Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice